Arthrex® AR-2326BCCRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00888867311282), received between Feb 22, 2021 and Sep 25, 2026 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Break” (15 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Physical Resistance/Sticking

  Patient problems: Insufficient Information

  MAUDE report 50898165 ↗
• MalfunctionSep 18, 2026Break

  On September 7, 2026, it was reported by an Arthrex employee via email that an AR-2326BCC BC SWIVELOCK, 3.9 X 17.9 MM 's tip was broken. This occurred during a procedure where after the anchor was inserted and tensioned, the tension was found to be insufficient, necessitating a retrial. However, upon removal of the anchor from the bone tunnel, the PEEK tip broke. The broken fragment has since been removed, and the surgery was completed successfully by using another AR-2326BCC. There was no reported patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819115 ↗
• MalfunctionAug 29, 2025Detachment of Device or Device Component; Damaged Thread; Detachment of Device or Device Component; Damaged Thread

  ON 08/12/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT TWO DEVICE ISSUES OCCURRED DURING A QUADRICEPS TENDON REPAIR PROCEDURE PERFORMED ON (B)(6) 2025. FIRST, AN AR-3780SP KNEE FIBERTAK BUTTON FAILED WHEN THE SUTURES COULD NOT BE PASSED THROUGH THE ANCHOR. WHILE ATTEMPTING TO PASS THE FIBERLINK SUTURE, IT BROKE, PREVENTING ANY SUTURE CONVERSION WITHIN THE ANCHOR. THE SUTURE WAS REMOVED, BUT THE ANCHOR REMAINED INTACT IN THE BONE AND WAS LEFT IN THE PATIENT. SECOND, AN AR-2326BCC BIOCOMPOSITE SWIVELOCK ANCHOR MALFUNCTIONED WHEN THE EYELET PREMATURELY DETACHED FROM THE INSERTION HANDLE DURING IMPLANTATION. THE THREAD ON THE EYELET WAS STRIPPED IN THE PROCESS. THE FAILED EYELET WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED USING AN AR-5511-CP INTERNALBRACE KNEE LIGAMENT AUGMENTATION REPAIR IMPLANT SYSTEM. THE PROCEDURE WAS DELAYED BY LESS THAN 15 MINUTES. IT IS UNKNOWN WHETHER ADDITIONAL ANESTHESIA WAS ADMINISTERED. BONE PREPARATION WAS PERFORMED USING AN AR-3710, AND THE PATIENT¿S BONE QUALITY WAS ASSESSED AS HARD. NO ADVERSE EFFECTS WERE REPORTED DURING OR AFTER SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22921907 ↗
• MalfunctionJun 3, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 5/8/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-2326BCC BIOCOMPOSITE SWIVELOCK EYELET ROTATED SIMULTANEOUSLY WITH THE ANCHOR DURING INSERTION. AS A RESULT, THE SUTURES BECAME ENTANGLED IN THE SCREW, RENDERING IT UNUSABLE. THE CASE WAS SUCCESSFULLY COMPLETED USING ANOTHER AR-2326BCC BIOCOMPOSITE SWIVELOCK. THIS ISSUE WAS INITIALLY DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION REQUESTED ON 5/29/2025.

  Patient problems: Insufficient Information

  MAUDE report 22131863 ↗
• MalfunctionMay 21, 2025Break; Break

  ON 04/29/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-2326BCC BIOCOMPOSITE SWIVELOCK ANCHOR BROKE DURING IMPLANTATION. THE SURGEON USED THE APPROPRIATELY SIZED DRILL AND TAP FOR THE SWIVELOCK, WITH THE FIRST 3.9MM SWIVELOCK FUNCTIONING AS INTENDED. HOWEVER, THE SECOND SWIVELOCK ANCHOR THAT WAS USED BROKE. TO COMPLETE THE REPAIR, AN ADDITIONAL AR-2326BCC BIOCOMPOSITE SWIVELOCK ANCHOR WAS USED. NO HARM WAS DONE TO THE PATIENT, AND NO EXTRA TIME WAS ADDED. ALL BROKEN PIECES WERE REMOVED. THIS WAS DISCOVERED DURING A HAMSTRING REPAIR PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22062769 ↗
• MalfunctionDec 6, 2024Break; Break

  ON 11/13/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2326BCC BIOCOMPOSITE SWIVELOCK EYELET IS LOOSE AND DETACHED WHEN INSERTION THE ANCHOR. IT ALSO WINDS UP IN THE SUTURES PULLING UNWANTED TENSION ONTO THE CONSTRUCT. THIS WAS DISCOVERED DURING A PROCEDURE. NO ADDITIONAL INFORMATION HAS BEEN REPORTED. ADDITIONAL INFORMATION RECEIVED ON 11/22/2024: THIS WAS DISCOVERED DURING AN RCR PROCEDURE. ALL SUTURE FRAGMENTS ARE REMOVED; HOWEVER, THE ANCHOR REMAINS IN THE PATIENT. THE CASE WAS DELAYED AT LEAST TEN MINUTES WITHOUT ADMINISTERING ADDITIONAL ANESTHESIA.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20869904 ↗
• MalfunctionSep 24, 2024Break; Break

  ON 09/12/2024, A SALES REPRESENTATIVE VIA SEMS-(B)(4) REPORTED THAT AN AR-2326BCC SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK ANCHOR BROKE DURING USE (SEE PHOTO). A SUTURE (1.5MM LABRALTAPE) WAS PLACED THROUGH THE TENDON AND LOADED INTO THE EYELET OF THE ANCHOR. A PILOT HOLE WAS DRILLED IN THE CALC TO ACCOMMODATE A 3.9MM SWIVELOCK. AS THEY SLID THE ANCHOR DOWN TO THE INCISION TO IMPLANT INTO THE BONE, THE SIDE OF THE EYELET BROKE AND WAS NO LONGER FUNCTIONAL. THE PATIENT WAS NOT INJURED AND THE CASE WAS COMPLETED WITHOUT ISSUES BY OPENING AN ADDITIONAL ANCHOR. THE ANCHOR AND EYELET WERE OBTAINED FROM THE CASE. THIS WAS DISCOVERED DURING AN ACHILLES TENDON REPAIR PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 9/18/2024: ALL FRAGMENTS WERE RETRIEVED. THE CASE WAS DELAYED LESS THAN 1 MINUTE WITH NO ADDITIONAL ANESTHESIA ADMINISTERED. A 3.4MM DRILL WAS USED TO PREPARE A PILOT HOLE. HOWEVER, THE ANCHOR NEVER MADE CONTACT WITH THE PATIENT. THE EYELET BROKE BEFORE THEY EVER INSERTED THE ANCHOR INTO BONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20290033 ↗
• MalfunctionSep 9, 2024Break; Break

  ON 08/16/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2326BCC BIOCOMPOSITE SWIVELOCK ANCHOR BROKE DURING INSERTION. ALL THE BROKEN FRAGMENTS WERE SUCCESSFULLY REMOVED. THE CASE WAS COMPLETED USING ANOTHER AR-2326BCC BIOCOMPOSITE SWIVELOCK. THIS WAS DISCOVERED DURING A PROXIMAL BICEP TENODESIS PROCEDURE ON (B)(6) 2024. THE CASE WAS NOT DELAYED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20170846 ↗
• MalfunctionAug 13, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED ON 8/13/2024: THIS WAS DISCOVERED DURING AN MPFL PROCEDURE ON (B)(6) 2024. ALL THE BROKEN FRAGMENTS WERE REMOVED FROM THE PATIENT. THE CASE WAS NOT DELAYED AS ANOTHER AR-2326BCC BIOCOMPOSITE SWIVELOCK WAS AVAILABLE IN THE OPERATING ROOM. ADDITIONAL ANESTHESIA WAS NOT NEEDED, AND THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19975524 ↗
• MalfunctionJun 18, 2024Break; Break

  ON 05/22/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT (2) AR-2326BCC SUTURE ANCHORS BROKE. THIS OCCURRED DURING A TIBIAL TUBERCLE AVULSION ON (B)(6) 2024 THE SURGEON USED THE PROPER DRILL FOR THE ANCHORS AND FOLLOWED THE TECHNIQUE AS ADVISED HOWEVER THE 2 ANCHORS BROKE WHILE BEING INSERTED AFTER A FEW THREADS WERE ENGAGED. AFTER THE SECOND ANCHOR BROKE THEY RE-DRILLED IN A DIFFERENT SPOT AND THE PROCEDURE CONTINUED WITH NO FURTHER ISSUES. ALL BROKEN PIECES WERE RETRIEVED.

  Patient problems: Insufficient Information

  MAUDE report 19557177 ↗
• MalfunctionJun 18, 2024Break; Break

  ON 05/22/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT (2) AR-2326BCC SUTURE ANCHORS BROKE. THIS OCCURRED DURING A TIBIAL TUBERCLE AVULSION ON (B)(6) 2024 THE SURGEON USED THE PROPER DRILL FOR THE ANCHORS AND FOLLOWED THE TECHNIQUE AS ADVISED HOWEVER THE 2 ANCHORS BROKE WHILE BEING INSERTED AFTER A FEW THREADS WERE ENGAGED. AFTER THE SECOND ANCHOR BROKE THEY RE-DRILLED IN A DIFFERENT SPOT AND THE PROCEDURE CONTINUED WITH NO FURTHER ISSUES. ALL BROKEN PIECES WERE RETRIEVED.

  Patient problems: Insufficient Information

  MAUDE report 19556862 ↗
• MalfunctionMay 16, 2024Break; Break

  ON 04/22/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-2326BCC SUTURE ANCHORS SUTURE EYELET BROKE OFF THE ANCHOR. THIS OCCURRED DURING AN ARTHROSCOPIC BICEPS TENODESIS PROCEDURE THE BICEPS HAD BEEN STITCHED, CUT, AND THE PILOT HOLE HAD BEEN MADE AND HAD BEEN LOADED WITH TWO AR-7535 SUTURE TAPE THEN INSERTED THROUGH THE CANNULA. PRIOR TO ANY TENSIONING THE SUTURE EYELET BROKE OFF THE ANCHOR. ANOTHER DEVICE WAS OPENED TO COMPLETE THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 19330982 ↗
• MalfunctionApr 16, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 3/20/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2326BCC BIOCOMPOSITE SWIVELOCK SUTURES ARE TWISTING UP AND THE EYELET IS NOT REVERSE THREADING OFF OF THE DRIVER. THE SWIVELOCK WAS INSPECTED AFTER THE PROCEDURE, AND IT APPEARS THE EYELET IS THREADED TOO TIGHTLY. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19115351 ↗
• MalfunctionApr 15, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 3/20/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2326BCC BIOCOMPOSITE SWIVELOCK SUTURES ARE TWISTING UP AND THE EYELET IS NOT REVERSE THREADING OFF OF THE DRIVER. THE SWIVELOCK WAS INSPECTED AFTER THE PROCEDURE, AND IT APPEARS THE EYELET IS THREADED TOO TIGHTLY. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19110843 ↗
• MalfunctionApr 11, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 11/28/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324BCC BIOCOMPOSITE SWIVELOCK. ANCHOR WARPED DURING INSERTION. CASE WAS COMPLETED WITH A DIFFERENT ANCHOR. THIS WAS DISCOVERED DURING AN ECLIPSE TSA PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON 12/2/2022: THE ANCHOR ONLY BENT AND DID NOT BREAK DURING INSERTION. CASE WAS COMPLETED WITH AN AR-2324BCC BIOCOMPOSITE SWIVELOCK.

  Patient problems: Insufficient Information

  MAUDE report 19086112 ↗
• MalfunctionJan 19, 2024Failure to Advance; Failure to Advance

  ON 12/27/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) AR-2326BCC BIOCOMPOSITE SWIVELOCK ANCHOR DO NOT ADVANCE IN THE BONE DURING INSERTION. THE SURGEON USED THE GUIDE TO DRILL AND FIND THE CORRECT TRAJECTORY TO INSERT THE ANCHOR. WHEN THE SURGEON MALLETS THE ANCHOR SO IT'S SCREWED TO THE BONE AND TWISTS, IT DOES NOT ADVANCE. THIS WAS DISCOVERED DURING A TSA SPEEDSCAP REPAIR PROCEDURE ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 18541848 ↗
• MalfunctionJan 19, 2024Failure to Advance; Failure to Advance

  ON 12/27/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) AR-2326BCC BIOCOMPOSITE SWIVELOCK ANCHOR DO NOT ADVANCE IN THE BONE DURING INSERTION. THE SURGEON USED THE GUIDE TO DRILL AND FIND THE CORRECT TRAJECTORY TO INSERT THE ANCHOR. WHEN THE SURGEON MALLETS THE ANCHOR SO IT'S SCREWED TO THE BONE AND TWISTS, IT DOES NOT ADVANCE. THIS WAS DISCOVERED DURING A TSA SPEED SCAP REPAIR PROCEDURE ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 18541831 ↗
• MalfunctionJan 8, 2024Break; Break

  ON 12/13/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2326BCC BIOCOMPOSITE SWIVELOCK EYELET BROKE WHEN TENSIONING THE ANCHOR. THE CASE WAS COMPLETED USING ANOTHER AR-2326BCC BIOCOMPOSITE SWIVELOCK. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 12/8/2023: THE AR-2326BCC BIOCOMPOSITE SWIVELOCK EYELET DID NOT BREAK INSIDE THE PATIENT. THE CASE WAS COMPLETED USING ANOTHER AR-2326BCC BIOCOMPOSITE SWIVELOCK. THE CASE WAS NOT DELAYED, ADDITIONAL ANESTHESIA WAS NOT NEEDED, AND THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18467560 ↗
• MalfunctionDec 13, 2023Break; Break

  DURING A ROTATOR CUFF REPAIR THE PEEK EYELET BROKE OFF DURING TENSIONING THE ANCHOR. ALL WAS RETRIEVED. IT WAS REPLACED WITH A 3.5 PUSH LOCK ANCHOR AND THERE WERE NO FURTHER ISSUES. THE PATIENT IS FINE TO DATE.

  Patient problems: Insufficient Information

  MAUDE report 18316878 ↗
• MalfunctionOct 23, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06044039 THAT AN AR-2326BCC BIOCOMPOSITE SWIVELOCK INSERTER BENT AND THE EYELET BROKE OFF. THE SURGEON HAD PLACED A CINCH STITCH AROUND THE BICEPS USING AN AR-13990N SCORPION NEEDLE AND AN AR-7235 FIBERLINK AND TWO CINCH STITCHES AROUND THE SUBSCAP USING (2) AR-7235T TIGERLINK. THEN, THE SURGEON PUNCHED FOR THE SWIVELOCK AND RAN THE SUTURE THROUGH THE EYELET. AS IT WAS BEING TENSIONED DOWN, THE EYELET BROKE OFF, AND THE TIP OF THE INSERTED BENT ABOUT NINETY DEGREES. THE EYELET AND INSERTER WERE REMOVED SUCCESSFULLY FROM INSIDE THE PATIENT. THIS WAS DISCOVERED DURING AN RCR PROCEDURE WITH BICEP TENODESIS ON (B)(6) 2023. THE CASE WAS COMPLETED USING A 4.75 SWIVELOCK AND PUNCHING A NEW BONE HOLE. ADDITIONAL INFORMATION WAS RECEIVED ON 10/2/2023: THE CASE WAS DELAYED TWO MINUTES; IT IS UNKNOWN IF ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: Insufficient Information

  MAUDE report 17984034 ↗
• MalfunctionDec 12, 2022Material Split, Cut or Torn

  ON (B)(6) 2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-2326BCC BIO-COMPOSITE SWIVELOCK SCREW SPLIT DURING INSERTION. ALL BROKEN FRAGMENTS WERE RETRIEVED, AND A NEW PRODUCT WAS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING AN ELBOW UCL PROCEDURE ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15959585 ↗
• MalfunctionJun 13, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2326BCC BIO-COMPOSITE SWIVELOCK EYELET BROKE UPON INSERTION. ONCE THE ANCHOR WAS DOWN TO THE BONE, THE EYELET BROKE AND WAS RETRIEVED AFTER REMOVING THE ANCHOR. THIS WAS DISCOVERED DURING AN RCR PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14674670 ↗
• MalfunctionApr 25, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2326BCC BIOCOMPOSITE SWIVELOCK EYELET FELL OFF THE INSERTER AND COULD NOT BE USED. A SECOND AR-2326BCC SWIVELOCK WAS OPENED AND THE ANCHOR BROKE OFF INSIDE THE PATIENT, ALL FRAGMENTS WERE RETRIEVED. AN AR-1665BCSL-39 LOOP-N-TAK WAS OPENED AND THE ANCHOR ALSO BROKE OFF INSIDE THE PATIENT, ALL FRAGMENTS WERE RECEIVED. SURGEON COMPLETED CASE WITH A BIGGER SWIVELOCK ANCHOR. THIS WAS DISCOVERED DURING A SUBSCAPULAR REPAIR ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 14194273 ↗
• MalfunctionDec 27, 2021Break

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT (2) AR-2326BCC SWIVELOCKS FAILED. THIS OCCURRED ON (B)(6) 2021 DURING A LARGE RCR. STANDARD TECHNIQUE AND INSTRUMENTATION WAS FOLLOWED FOR INSERTION OF THE SWIVELOCK FOR LATERAL ROW FIXATION. THE SUTURE WAS LOADED INTO THE ANCHOR AND THE EYELET WAS PARTIALLY INSERTED BY HAND INTO THE PREPARED SOCKET. THE SURGEON TAPPED THE SWIVELOCK WITH A MALLET TO DRIVE IT DOWN INTO THE BONE AND THE TIP SNAPPED OFF. ALL FRAGMENTS OF THIS BROKEN DEVICE WERE RETRIEVED, AND A NEW ANCHOR WAS LOADED AND INSERTED IN STANDARD FASHION. THIS TIME THE SWIVELOCK ANCHOR BODY WOULD NOT ADVANCE INTO THE BONE. THE SURGEON REMOVED ALL PARTS OF THE IMPLANT AND PROCEEDED TO USE A 4.75M SWIVELOCK TO COMPLETE THE CASE. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13087968 ↗
• MalfunctionFeb 22, 2021Break

  IT WAS REPORTED THAT THE EYELETS OF TWO AR-2326BCC BROKE WHEN THE SURGEON WAS TENSIONING THE SUTURES. THE ANCHORS WERE REMOVED FROM THE PATIENT AND PUSHLOCKS WERE USED TO COMPLETE THE RCR CASE.

  Patient problems: Insufficient Information

  MAUDE report 11357618 ↗